Sterile Facility Upgrade - Vistakon J&J, Ireland

Vistakon is a Medical Technology company and a subsidiary of the Johnson and Johnson Corporation and had a requirement to upgrade an existing Sterile Fill Facility to carry out media fills and clinical trials in their plant in Limerick, Ireland.

DPS was awarded the Design activities associated with modifications to the process and clean utilities and the Qualification activities for the facility.

Qualification activities included IQ and OQ of process and clean utility modifications to the facility, PQ of clean utilities, CIP qualification, Thermal Mapping of SIP processes, HVAC Qualification and Environmental Qualification of the areas in order for Media Fill and Clinical Trails to progress.

Equipment and Systems include:

Incubators
Formualtion preparation and transfer lines
Sterilisation / Filtration skid and transfer lines
Filling Machine
Purified Water Generation and Distribution
Clean Steam generation and distributions
Clean Air distribution
HVAC system grades A, B, C & D